A Bioequivalence Study of Capecitabine 500 mg with Xeloda 500 mg in Adult Cancer Patients Under Fed Conditio
- Conditions
- Health Condition 1: R971- Elevated cancer antigen 125 [CA 125]
- Registration Number
- CTRI/2024/05/068024
- Lead Sponsor
- BIOPHARM SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Males or non-pregnant or non-lactating females of age between greater than 18 to 60 years (both inclusive)
2 Patients in whom capecitabine therapy is indicated Dukes’ C colon cancer Single agent as adjuvant therapy or Metastatic colorectal cancer First line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred or
Metastatic Breast Cancer As monotherapy in patients resistant to both paclitaxel and an anthracycline containing regimen
3 Patients already receiving a stable twice-daily dosing regimen of capecitabine (1250 mg/m2 twice daily equivalent to 2500 mg/m2 total daily dose for two-weeks followed by a one-week
rest period given as three-week cycles)
4 Patients with Eastern Cooperative Oncology Group (ECOG) performance status = 2
5 Patients with life expectancy of at least 3 months
6 Adequate cardiac function [left ventricular ejection fraction LVEF = 50 %
7 Patient with adequate
- Bone marrow (ANC = 1500/mm3, Platelet count =
100,000/mm3 Hemoglobin = 9.0 g/dL)
- Renal (Serum Creatinine = 1.5 times ULN and creatinine clearance = 51 to 80 mL/min [Cockroft and Gault]) and
- Hepatic function (Bilirubin = 1.5 times ULN, ALT/AST = 3 times ULN (= 5 x ULN if liver metastases present))
8 Patients should be non-smokers
9 Patient willing and able to give written informed consent for participation in the study and comply with the study protocol
10 No persistent clinically significant toxicities from prior medications at screening.
11 Females of child-bearing potential must agree to use an acceptable method of birth control such as sexual abstinence or at least reliable modes of contraception from screening until 3 months after last dose of study drug
[Note Use of hormonal contraception(pills/hormonal
intrauterine device etc) is not allowed
OR Post-menopausal females defined as at least 12 consecutive months with no menses without an alternative medical cause
OR surgically sterilized females with documented evidence of hysterectomy/bilateral salpingectomy/bilateral oophorectomy
12 Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception (condom) from screening until 3 months after last dose of study drug Subject agrees to accept the risk that
pregnancy in female partner could still result despite using birth control devices
13 Cancer patients should preferably be on monotherapy However cancer patients receiving concomitant drug(s) are allowed to participate provided
- The concomitant medication is the same for all the study
period and clearly documented.
- Patients do not require any change in their concurrent
medications during the study period
1 Patients with known hypersensitivity to capecitabine or to any of its components of formulation or 5-fluorouracil
2 Patients with known DPD (Dihydro pyrimidine
Dehydrogenase) deficiency
3 Prior unanticipated severe reaction to Capecitabine or metabolites and to fluoropyrimidine therapy
4 Patients with a prior history of coronary artery disease
5 Patients who are on oral-coumarin derivative anticoagulants such as warfarin or phenprocoumon at the time of screening or anticipated use of these drugs during the study period[If the
subject was on any of these drugs before screening a wash out
19 Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial period of at least 5 half-lives must have elapsed since the last
dose of such drug
6 Patients receiving concomitant therapy of Phenytoin Leucovorin and CYP2C9 substrates at the time of screening or anticipated use of these drugs during the study period [If the
subject was on any of these drugs before screening a wash out period of at least 5 half-lives must have elapsed since the last dose of such drug] Presence of active infections
7 Patients with known brain metastasis.
8 Pre-existing motor or sensory neurotoxicity of severity = 2 by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria
9 Use of any recreational drugs or history of drug addiction
10 Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening
11 Consumption of grapefruit grapefruit-like or grapefruit containing products within 7 days prior to study drug administration
12 Use of enzyme modifying drugs within 30 days prior to study drug administration They can be allowed depending on Principal Investigator’s discretion if they are kept constant in
the last 30 days and are expected to remain constant during the study period
13 Major surgery to the gastrointestinal tract, liver or kidney within 3 months prior to study entry which may affect the pharmacokinetics of capecitabine
14 History of difficulty in swallowing or any gastrointestinal disease e.g. ulcerative colitis ulcerative stomatitis malabsorption syndrome and/or lack of physical integrity of the
upper intestinal tract which could affect drug absorption
15 History or presence of cardiac disease including myocardial infarction unstable angina coronary artery disease heart failure dysrhythmias cardiomyopathy significant pericardial
disease or any other cardiac illness that could affect patient safety
16 Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
17 History or evidence of uncontrolled coagulopathy.
18 Patients with severe hepatic or renal impairment
19 Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial
20 Patients who have had experienced a severe mucocutaneous reaction during prior capecitabine treatment
21 History of difficulty with donating blood or difficulty in accessibil
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method